Connector having a membrane, for connecting a syringe to a container or tubing

ABSTRACT

The invention relates to a device for connecting a syringe to a container or tubing, particularly for connecting a syringe to a container for receiving infusion-, transfusion-, or enteral nutrition solutions and particularly for connecting a syringe to tubing of a blood tube system of an extracorporeal blood treatment device or to tubing for a venous portal. The invention also relates to a container and tubing with such a device. The device according to the invention has a connecting part ( 2 ) which connects to the container or the tubing, the connecting part having a recess ( 3 ) in which a membrane ( 12 ) is arranged, the membrane closing the channel-shaped recess. A hollow body ( 22 ) having a syringe ( 23 ) is arranged in the recess ( 3 ) of the connecting part ( 2 ) in such a manner that the membrane ( 12 ) is pierced upon connection of the syringe to the connecting part. The device according to the invention is characterized in that the membrane ( 12 ) is arranged above the hollow body ( 22 ) in the connecting part ( 2 ) recess ( 3 ), such that upon connection of the syringe to the connecting part, the membrane is pressed onto the tip of the hollow body.

The invention relates to a device for connecting a syringe to a container or tubing, in particular for connecting a syringe to a container for holding infusion, transfusion or enteral nutrient solutions, and in particular for connecting a syringe to tubing of a blood tube system of an extracorporeal blood treatment device or tubing for venous access. Furthermore, the invention relates to a container and to tubing with a device of this type.

DE-A-197 28 775 describes an infusion bag with an injection part and a withdrawal part. The injection part is intended for delivery of a medicament by means of an injection syringe, whereas the withdrawal part is used for withdrawing the solution by means of a spike. The injection and withdrawal parts have a tubular connecting part which is sealed by a protective cap designed as a break-off part.

Tapered connections having a tapered stem and a tapered sleeve, the tapered surfaces of which are standardized, are known in medical technology for connecting medical implements. The tapered connections which are not lockable and have standardized tapered surfaces are referred to as Luer connectors and the lockable tapered connections are referred to as Luer lock connectors. The Luer connectors or Luer lock connectors with a tapered shaft are referred to as male connectors and connectors with a tapered sleeve are referred to as female connectors.

An infusion bag with connectors for delivering and withdrawing liquids is also known from DE-A-103 48 016. The connector for delivering a liquid permits connection of a conventional syringe to a tapered connection, in particular a Luer lock tapered connection, which does not have an injection needle. Since an injection needle having a small cross section is not required, relatively viscous active substances can also be injected rapidly. There is no risk of injury to the nursing staff. There is also no risk of the infusion bag being damaged. The possibility of screwing together the syringe and the connector ensures that the connection does not become detached. The connector has a self-sealing, slit membrane which is pierced by the tapered shaft of the syringe. After the tapered shaft is pulled out, the membrane closes again and therefore prevents the liquid from running out of the bag. The connector has proven successful in practice. However, a requirement for correct functioning of the known connector is that the membrane can open easily and reliably.

EP-A-0 681 493 describes a connector for connecting a syringe, which connector is based on a different functioning principle from the connector described above. The known connector has a hollow pin which is arranged within a stopper tightly sealing the connector. The pin has a plurality of lateral openings below its point. When the syringe is connected to the connector, the stopper surrounding the pin is displaced by the tapered shaft of the syringe such that the pin penetrates the tapered shaft. A liquid connection is therefore produced between the syringe and the connector via the lateral openings of the pin.

EP 0 309 771 A1 describes a device for injecting liquids into a channel of a cannula connecting piece, said device having a membrane which is pierced by a cannula upon connection of the cone of a syringe. In this case, the basic principle involves the tapered shaft of the syringe taking hold of a clamping sleeve which surrounds the membrane and is supported on a lower flange of the membrane. As a result, the membrane is pushed over the cannula. The production and assembly of the known device is relatively costly and complicated because of the additional clamping sleeve.

U.S. Pat. No. 7,396,051 B2 describes an arrangement of connectors, in which a membrane of one connector is penetrated by a hollow body, the hollow body advancing into a cylindrical body of the other connector. However, the cylindrical body is not the cone of a syringe.

The invention is based on the object of providing a device which permits simple connection of a syringe to a container or to tubing without the risk of injury, wherein the device securely seals the container or the tubing after removal of the syringe. This object is achieved by the features specified in patent claim 1.

Furthermore, it is an object of the invention to provide a container or tubing with a device permitting simple connection of a syringe to the container or the tubing without the risk of injury. This object is achieved by the features of patent claims 15 and 19.

Advantageous embodiments of the invention are the subject matter of the dependent claims. The device according to the invention has a connecting part which is to be connected to the container or the tubing and has a recess in which a membrane, with which the recess is closed, is arranged. Furthermore, a hollow body with a point is arranged in the recess of the connecting part in such a manner that the membrane is pierced when the syringe is connected to the connecting part.

The device according to the invention is distinguished in that at least that part of the membrane which is pierced is arranged above the hollow body in the recess of the connecting part and therefore, when the syringe is connected to the connecting part, that part of the membrane which is to be pierced is pressed onto the point of the hollow body. The effect achieved by this is that the membrane can be easily and reliably pierced without there being the risk of the membrane twisting.

In the arrangement according to the invention of the syringe with the tapered shaft and the device for connecting the syringe to a container or tubing, the tapered shaft of the syringe and the hollow body are arranged in such a manner that the tapered shaft of the syringe is sealed in relation to the hollow body when the syringe is connected to the device. When the syringe is connected to the connecting part, the point of the syringe presses the membrane directly onto the hollow body. In the process, the point of the syringe acts directly on the membrane.

When the syringe is connected to the device, the tapered shaft of the syringe is not only sealed in relation to the hollow body but also in relation to the connecting part having the preferably conical connecting piece of the device such that both parts are securely sealed off from each other, this being crucial in particular when administering cytostatics.

Since the point of the syringe is advantageously arranged at a distance from the preferably slit membrane, unintentional opening of the membrane is prevented even if the two containers with the device according to the invention are to be sterilized, in which case there is the risk of the membrane being deformed because of the positive pressure arising in the container.

In a preferred embodiment, at least that part of the membrane which is pierced and the hollow body are arranged at a distance from each other in the recess of the connecting part. However, it is in principle also possible for the point of the hollow body to come into contact with the membrane. The sole crucial factor is to ensure that the membrane is not damaged by the point of the hollow body before the syringe is connected to the connecting part.

In a particularly preferred embodiment, the hollow body, with which the membrane is pierced, is designed as a cannula with a ground section. Consequently, the hollow body does not need to have any lateral openings or slits. The liquid can flow in the axial direction into the lumen of the cannula.

Another particularly preferred embodiment of the invention makes provision for the hollow body in the recess of the connecting part to be fastened to a disk-shaped body which preferably has openings. The openings in the disk-shaped body are preferably bores distributed circumferentially around the hollow body. This preferred embodiment has the advantage that the container to which the device is connected can be filled through the openings. Another advantage is that, when required, injection of additional liquids, for example insulin or heparin, by a syringe with an injection needle (cannula) is in principle possible, optionally even directly through the openings.

The membrane is preferably slit in order to sealingly receive the tapered shaft of a syringe. This facilitates the piercing of the self-sealing membrane, in particular by a hollow body composed of plastic. After the tapered shaft of the syringe has been pulled out, the membrane can be closed again, and therefore liquid is prevented from running out of the container or the tubing. However, it is also possible for the membrane not to be slit, in particular if the hollow body (pin) is a metal pin.

The connecting part preferably has an external thread for connection of a Luer lock syringe which can be screwed securely to the connecting part. However, it is also possible that the connecting part does not have an external thread, and therefore only a Luer syringe without a screw thread can be connected.

In a particularly preferred embodiment, the connecting part is composed of an upper subsection and a lower subsection which are fixed by clicking into place. In this embodiment, for the fastening of the hollow body, the disk-shaped body is preferably arranged at the upper end of the lower subsection. The membrane is preferably held clamped between the upper and lower subsections. This facilitates the assembly. However, the connecting part may also be a single piece.

The membrane preferably has an upper, plate-like portion which is adjoined by an annular, lower portion. In this embodiment, the lower, annular portion of the membrane is preferably held clamped between the upper and lower subsections of the connecting part, whereas the plate-like portion is completely pierced by the point of the hollow body upon connection of the syringe.

The upper side, preferably, of the membrane has a trough-shaped depression which firstly ensures that the tapered shaft of the syringe is reliably guided and secondly it is ensured that the membrane is reliably sealed after the tapered shaft is pulled out.

The recess-closing break-off part of the device according to the invention is advantageously designed as a flat gripping piece in order to be able to be held by the thumb and index finger, thus simplifying the handling. The break-off part can be connected to the connecting part of the device via an annular breaking zone, and therefore, although the break-off part has a secure grip, it can nevertheless be detached relatively easily.

The device according to the invention is expediently an injection molded part which can be produced cost-effectively in large piece numbers.

The container according to the invention for medicinal liquid is distinguished in that the device according to the invention is connected to the container. For this purpose, the connecting part of the device may differ in design. Adhesive bonds and/or welding connections are possible. The container may be a bag, in particular an infusion or transfusion bag or a bag for holding an enteral nutrient solution, with it being possible for the connecting part to be designed as a closure part which is to be welded or adhesively bonded to the bag. However, the container may also be a bottle, with it being possible for the device to be designed as a closure cap or for the connecting part of the device to be designed as an adapter for the closure of a bottle.

The tubing according to the invention for medicinal liquids is distinguished in that the device according to the invention is connected to the tubing. The tubing may be, for example, part of a blood tube system of an extracorporeal blood treatment device or tubing for venous access.

A number of exemplary embodiments of the invention are explained in more detail below with reference to the drawings, in which:

FIG. 1 shows an exemplary embodiment of the device according to the invention in side view,

FIG. 2 shows a section through the device from FIG. 1 along the line A-A,

FIG. 3 shows a section through the device of FIG. 2 along the line C-C,

FIG. 4 shows the detail A from FIG. 2 in an enlarged illustration,

FIG. 5 shows the lower subsection of the device in a perspective illustration,

FIG. 6 shows the device from FIGS. 1 to 5 with a connected syringe in a sectioned illustration,

FIG. 7 shows an infusion or transfusion bag with the device according to the invention in a partially sectioned illustration,

FIG. 8 shows a section through a second exemplary embodiment of the device according to the invention,

FIG. 9 shows the device from FIG. 8 with the connected syringe in a sectioned illustration,

FIG. 10 shows a section through a third exemplary embodiment of the device according to the invention,

FIG. 11 shows the device from FIG. 10 with the connected syringe in a sectioned illustration,

FIG. 12 shows a fourth exemplary embodiment of the device according to the invention, and

FIG. 13 shows a fifth exemplary embodiment of the device according to the invention.

FIGS. 1 to 6 show a first exemplary embodiment of the device according to the invention which is intended for connecting a syringe to a container. FIGS. 1 and 2 show the device according to the invention in side view and in a sectioned illustration, in which the syringe is not connected to the device.

The device 1 according to the invention is designed as an injection part for injecting an active substance into a container which contains a medicinal liquid, in particular into an infusion or transfusion bag. The device according to the invention is therefore a connector 1.

The connector 1, which is an injection molded part made of polypropylene, has a connecting part 2 with a channel-shaped recess 3 which, in the use position, is composed of a bag-side lower subsection 4 and a connection-side upper subsection 5. The lower subsection 4 of the connecting part 2 has a lower and upper substantially cylindrical portion 6, 7, wherein the lower portion 6 has a smaller external diameter than the upper portion 7. The lower portion 6 can be inserted or pushed into a connecting piece of a film bag and can be welded or adhesively bonded to the connecting piece. However, it may also be welded or adhesively bonded directly into the film bag without a connecting piece.

The lower and upper subsections 4, 5 of the connector 1 are connected to each other by clicking into place. For this purpose, the outer wall of the upper cylindrical portion 7 of the lower subsection 4 of the connecting part 2 has an encircling extension 8 which, when the two subsections 4, 5 are pressed together, clicks into an encircling groove 9 on the inner wall of the upper subsection 5 of the connecting part 2. The lower edge 10 of the upper subsection 5 is supported here on an encircling projection 11 at the lower end of the upper cylindrical portion 7 of the lower subsection 4.

A self-sealing membrane 12 composed of an elastic material, also referred to as a septum, is held clamped with elastic deformation between the lower and upper subsections 4, 5 of the connecting part 2. The membrane 12 has an annular, lower portion 13 which is clamped between the lower and upper subsections 4, 5 of the connecting part 2. The lower, annular portion 13 of the membrane 12 is adjoined by an upper, plate-like portion 14. In the center of the plate-like portion 14, the membrane 12 is provided with a continuous slit 15. The membrane 12 may be provided with just one transversely running slit or else may be slit crosswise or in the shape of a star. The slit preferably extends virtually over the entire cross section of the plate-like portion 14 of the membrane. On the upper side of the plate-like portion 14, the membrane 12 has a trough-shaped depression 16 in the center.

Above the membrane 12, the connecting part 2 is designed as a connecting piece which has an internal cone 17 and an external thread 18. The internal cone 17 and external thread 18 correspond to the tapered shaft of a Luer lock tapered connection of a conventional Luer lock syringe, and therefore the tapered shaft of the Luer lock syringe can be pushed into the internal cone of the connecting piece in a sealing manner and can be screwed securely to the connecting part.

A cap-shaped break-off part 20 which closes the channel-shaped recess 3 of the connecting part 2 adjoins the connecting piece 2 of the connector 1 via an annular breaking zone 19. The break-off part 20 forms a tamper-evident closure for the connector. It has a lower, rotationally symmetrical base part 20A and an upper, flat gripping piece 20B. The flat gripping piece 20B is provided with a cut-out 21 which is designed in the manner of a downwardly pointing arrow and identifies the connector as the injection part.

Upon connection of a Luer lock syringe to the connector, the membrane 12 is pierced. For this purpose, the connector 1 has a hollow body 22 with a point 23. The hollow body with the point is designed as a cannula 22 with a ground section 23 which has two mutually opposite, lateral ground surfaces 23A and 23B.

The sharpened cannula 22 is fastened in the center of a disk-shaped body 24 which is integrally formed on the upper end of the lower subsection 4 of the connecting part 2. The disk-shaped body 24 has a plurality of bores 25 which are distributed circumferentially around the cannula 22.

The cannula 22 extends from the disk-shaped body 24 of the lower subsection 4 of the connecting part 2 into the cylindrical recess 26 which is enclosed by the lower, annular portion 13 of the membrane 12. In this case, only a narrow gap 27 remains between the lower side of the upper, plate-like portion 14 of the membrane 12 and the point 23 of the cannula 22.

In order to secure the lower subsection 4 in the upper subsection 5 of the connecting part 2 against twisting, the lower subsection 4 has an external toothing 28 above the encircling extension 8 and the upper subsection 5 has a corresponding internal toothing 29, said toothings engaging one inside the other when the two parts are joined together.

To inject an active substance, the break-off part 20 of the connector 2 is twisted off or broken off by rotation or breaking of same such that the self-sealing membrane 12 is exposed. A conventional Luer lock syringe is then screwed to the connector 2.

FIG. 6 shows the connector 2 with the break-off part 20 broken off, wherein the Luer lock syringe 28 is screwed onto the connector, thus producing a liquid connection between the syringe and the connector. When the Luer lock syringe 28 is screwed on, the front end of the tapered shaft 29 of the syringe 28 pushes onto the trough-shaped depression 16 in the plate-like portion of the membrane 12. When the tapered shaft is advanced further as the syringe is being screwed on, the tapered shaft presses the upper, plate-like portion 14 of the membrane 12 downward, as a result of which the lower side of the membrane pushes onto the point 23 of the cannula 22. When the tapered shaft is advanced even further as the syringe is being screwed on, the cannula 22 pierces the pre-slit membrane 12, with the cannula 22 penetrating the cylindrical recess 30 of the tapered shaft 29. When the syringe has been completely screwed on, a narrow gap 31 remains between the tapered shaft 29 of the syringe 28 and the disk-shaped body 24 of the lower subsection 4 of the connecting part 2.

Upon unscrewing of the syringe 28, the tapered shaft 29 is pulled back again, as a result of which the upper, plate-like portion 14 of the membrane 12 can return back into the starting position thereof in order to securely close the connector. Since the membrane 12 is pre-slit, the point 23 of the cannula 22 can penetrate the membrane 12 without damaging the membrane. This ensures that the membrane closes the connector tightly again when the syringe is unscrewed.

FIG. 7 shows an infusion or transfusion bag 32 together with the connector 1. The bag 32 consists of two film layers 32A and 32B which are welded to each other at the edges 32C. FIG. 7 illustrates just one portion of the bag. The connector 1 is welded into the upper edge of the bag. The lower subsection 4 of the connecting part 2 of the connector 1 is pushed into the connecting piece 32D and is welded to the connecting piece during the sterilization operation. Prior to the assembly of the connector 1, the bag 32 can be filled with a transfusion or infusion solution, but also with an enteral nutrient solution via the bores 25 in the lower subsection 4 of the connecting part 2 when the lower and upper subsections 4, 5 are not yet connected to each other.

Further exemplary embodiments of the device according to the invention, which differ from the connector described with reference to FIGS. 1 to 6 only in that the connecting part differs in design, are described below. Whereas the connector from FIGS. 1 to 6 is intended for connection to a bag, the devices described below are intended for connection to a bottle or tubing. Since the individual connectors differ only by the design of the connecting part 2, in particular of the lower portion 6 of the lower subsection 4 of the connecting part 2, only the differences over the first exemplary embodiment of the connector according to the invention are described below. The mutually corresponding parts are provided with the same reference numbers in the figures.

FIGS. 8 and 9 show an embodiment of the connector 1′ according to the invention in a sectioned illustration, wherein FIG. 8 shows the connector 1′ before connection of the syringe 28 and FIG. 9 shows the connector after connection of said syringe. In this exemplary embodiment, the lower portion of the lower subsection 4 of the connector is designed in the manner of a boat 33 which can be welded or adhesively bonded to a film bag. Boats of this type are known to a person skilled in the art. They are designed as flat bodies with lateral webs 33A and 33B.

FIG. 10 shows an exemplary embodiment of the device 1″ according to the invention which is intended for connection to a bottle. FIG. 11 shows the device 1″ which is connected to the bottle 34. The bottle 34 is a conventional bottle for holding a medicinal liquid and is tightly closed by a stopper 35.

The device according to the invention, which is designed as a connection adapter, has a spike 36 for piercing the stopper 35 of the bottle 34. The spike 36 extends downward from the upper, cylindrical portion 7 of the lower subsection 4 of the device. The spike 36 is surrounded by a cylindrical subsection 37 which is likewise integrally formed on the upper portion 7 of the lower subsection 4. The inside of the cylindrical subsection 37 has a plurality of webs 38 and is provided with a plurality of slits 39 such that it can be placed onto the closure of the bottle 34. In the process, the stopper 35 of the bottle is pierced, thus enabling withdrawal of liquid using a Luer lock syringe 28.

FIG. 12 shows a further exemplary embodiment of the device 1′″ according to the invention which is intended for connection to tubing 40, for example tubing for venous access. In this embodiment, the lower portion 6 of the lower subsection 4 of the device is designed as a hollow-cylindrical connecting piece 41 which is dimensioned in such a manner that the tubing 40 can be pushed onto the connecting piece 41 and can be welded or adhesively bonded to said connecting piece. Otherwise, the embodiment of FIG. 12 does not differ in construction and manner of operation from the exemplary embodiments described above.

FIG. 13 shows a further exemplary embodiment of the device 1″″ according to the invention which is designed as a closure cap for a bottle. The closure cap has a round cover part 42 which is adjoined by a cylindrical side part 43. A flange 44 for fastening the cap to a bottle head is situated on the lower edge of the side part 43.

The closure cap 1″″ according to the invention has a port system 45 which comprises an injection point 46 for injecting liquid and a withdrawal point 47 for withdrawing liquid. Both the injection point 46 and the withdrawal point 47 are closed by a break-off part 48, 49 which identifies the two points of the port system as an injection part or withdrawal part by a respective arrow 50, 51.

In this embodiment, the cover part 42 and the cylindrical side part 43 represent the connecting part of the device 1″″ according to the invention which is placed onto the bottle (not illustrated in FIG. 13).

At the injection point 46, the round cover part 42 of the closure cap 1″″ has a recess 3′ in which a self-sealing membrane 12′, with which the recess is closed, is arranged. Said membrane is identical to the membrane described with reference to the preceding exemplary embodiments. In this embodiment too, upon connection of a syringe to the closure cap, the membrane 12′ is pressed onto the point of a hollow body 22′ which is arranged below the membrane 12′. In this embodiment, the point 23′ of the hollow body 22 is not, however, at a distance from the membrane 12′ but rather is directly therebelow.

The hollow body 22′ for piercing the membrane 12′ upon connection of the syringe is integrally formed on a disk-shaped body 24′ which sits together with the membrane in the recess 3′ of the cover part 42 of the closure cap. The membrane 12′ and the hollow body 22′ together with the disk-shaped body 24′ are held clamped in the recess 3′ by a projecting, encircling extension 52 which engages under the disk-shaped body 24′. In this case, the lower portion of the membrane is supported in the recess 3′ of the cover part 42 of the closure cap by means of an upper, projecting extension and the disk-shaped body is supported therein by means of a lower, projecting extension 54. However, it is also possible to adhesively bond or to weld the disk-shaped body to the cover part of the closure cap. In this embodiment, the withdrawal point 47 of the closure cap does not have the connection according to the invention. Therefore, the withdrawal point of the closure cap is also not described in more detail. 

1. A device for connecting a syringe to a container or tubing, with a connecting part which is to be connected to the container or the tubing and has a recess in which a membrane is arranged, a break-off part which closes the recess of the connecting part and is connected to the upper end of the connecting part, a hollow body with a point which is arranged in the recess of the connecting part, wherein the membrane and the hollow body are arranged in the recess of the connecting part in such a manner that the membrane is pierced when the syringe is connected to the connecting part, wherein: the membrane is arranged above the hollow body in the recess of the connecting part and therefore, when the 30 syringe is connected to the connecting part, the membrane is pressed by the syringe onto the point of the hollow body, and; the membrane and the hollow body are arranged at a distance from each other in the recess of the connecting part.
 2. (canceled)
 3. The device as claimed in claim 1, wherein the hollow body is designed as a cannula with a ground section.
 4. The device as claimed in claim 3, wherein the hollow body in the recess of the connecting part is fastened to a disk-shaped body which has openings.
 5. The device as claimed in claim 4, wherein the openings in the disk-shaped body are bores distributed circumferentially around the hollow body.
 6. The device as claimed in claim 1, wherein the membrane is slit in order to sealingly receive the tapered shaft of a syringe.
 7. The device as claimed in claim 1, wherein the connecting part has an external thread for the connection of a Luer Lock syringe.
 8. The device as claimed in claim 4, wherein the connecting part consists of a lower subsection and an upper subsection which are fixed by clicking into place, with the disk-shaped body being arranged at the upper end of the lower subsection.
 9. The device as claimed in claim 8, wherein the membrane is held clamped between the lower subsection and the upper subsection of the connecting part.
 10. The device as claimed in claim 8, wherein the membrane has an upper, plate-like portion which is adjoined by an annular, lower portion.
 11. The device as claimed in claim 10, wherein the lower, annular portion of the membrane is held clamped between the lower subsection and the upper subsection of the connecting part.
 12. The device as claimed in claim 1, wherein the upper side of the membrane has a trough-shaped depression.
 13. The device as claimed in claim 1, wherein the break-off part is designed as a flat gripping piece which is connected to the upper end of the connecting part via an annular breaking zone.
 14. An arrangement of a syringe with a tapered shaft and a device as claimed in claim
 1. 15. A container for medicinal liquids with a device as claimed in claim 1, wherein the connecting part of the device is connected to the container.
 16. The container as claimed in claim 15, wherein the container is a bottle 10, with the connecting part of the device being designed as an adapter for the bottle.
 17. The container as claimed in claim 15, wherein the container is a bottle 15, with the device being designed as a closure cap of the bottle.
 18. The container as claimed in claim 15, wherein the container is a bag, in particular an infusion or transfusion bag or a bag for holding an enteral nutrient solution, with the connecting part of the device being designed as a closure part which is to be welded and/or adhesively bonded to the bag.
 19. A tubing for medicinal liquids with a device as claimed in claim 1, with the connecting part of the device being connected to the tubing. 